INSERTION DEVICE FOR AN INFUSION SET
An insertion device for an infusion set includes an advancement unit or a sliding element for moving the infusion set along a central axis from a proximal position into a distal position, a retaining element for retaining the infusion set that includes a guide element, a base part for accommodating the retaining element that includes a mating guide element and a contact surface for placing the insertion device on an application point of a patient's body, and a head part arranged rotatably about a central axis in relation to the base part. Upon relative rotation between the head part and the base part in one direction, the guide element of the retaining element can be guided with the mating guide element provided on the base part such that the retaining element is movable along the central axis relative to the base part from the distal position into the proximal position.
This application claims priority to Swiss Patent Application No. 01157/14 filed Jul. 29, 2014, the contents of which are hereby incorporated by reference.
BACKGROUNDThe present invention relates to an insertion device for an infusion set.
Infusion sets are known from WO02/070037A2 and from WO2005/049117A2, for example. Such infusion sets are used for insulin therapy, for example, wherein insulin is transported by the infusion pump into the body of a diabetic with the aid of an infusion set. The infusion set comprises a cannula, which is preferably placed directly under or in the skin by means of an insertion device or a puncturing aid, and held in place with an adhesive bandage.
An insertion device for such an infusion set is known from EP1487519B1 for example. The disadvantage with this insertion device is that, before the infusion set can be inserted into the device, an advancement unit for inserting the infusion set must be preloaded from a rest position into an operation-ready position.
Additional insertion devices or puncturing aids for an infusion set are known from EP1970084B1, EP1631337B1 and EP1970083A1. The insertion devices have in common the fact that the technology of these insertion devices is based on a lever mechanism; the insertion devices are consequently complicated in structure and have many components.
SUMMARYA problem addressed by the present invention is therefore the provision of an insertion device that is easier to use and has a simpler structure. Another problem addressed by the present invention is the provision of an infusion set having such an insertion device with a simpler and safer procedure.
This problem is solved by the subject matter of the independent claims. Advantageous embodiments follow from the dependent claims.
Hereinafter, a proximal position of the insertion device means a position in which an advancement unit for conveying the infusion set into the skin is in a cocked position, and a distal position of the insertion device means a position in which the advancement unit for conveying the infusion set into the skin is in a relaxed position.
The invention relates to an insertion device for an infusion set, having an advancement unit for moving the infusion set from a proximal position into a distal position along a central axis (z). The insertion device may comprise a retaining element for holding the infusion set and a base part with a contact surface for placement of the insertion device on an application point on a patient's body, the base part being accommodated by the retaining element. The retaining element has at least one retaining arm for retaining the infusion set, preferably two or a multiple of two retaining arms. The retaining arm is preferably designed such that a retaining wing provided on the infusion set can be snapped into and out of the retaining arm. The retaining arm is preferably elastic. The insertion device further comprises a head part, which is arranged rotatably about a central axis (z) in relation to the base part. If there is a relative rotation between the head part and the base part in a first rotational direction, a guide element mounted on the retaining element can be guided with a mating guide element provided on the base part, the retaining element being movable along the central axis (z) relative to the base part from a distal position into a proximal position.
If there is a relative rotation between the head part and the base part in a second rotational direction, the guide element of the retaining element can be guided with the mating guide element provided on the base part, the retaining element being movable along the central axis (z) relative to the base part from the proximal position into the distal position. In other words, the retaining element can be moved along the (z) axis since the guide element of the retaining element is in a guiding engagement with the mating guide element provided on the base part.
Preferably the guide element of the retaining element is designed as a guide cam track and the mating guide element of the base part as a guide cam. Alternatively, the guide element of the retaining element is designed as a guide cam and the mating guide element of the base part as a guide cam track. A different guide element or a different mating guide element can also be provided, assuming that the guide element and the mating guide element are in a guiding engagement.
The retaining element is preferably connected rotationally fixedly to the head part. The head part can rotate along with the retaining element relative to the base part in a first direction and/or a second direction.
A cover can additionally be rotationally fixedly connected to the head part. Alternatively, the cover can be integrally formed with the head part. The head part is preferably accommodated on the cover at the proximal end.
The advancement unit can preferably have an elastic means and a sliding element. If there is a relative rotation between the head part and the base part in the first rotational direction, the elastic means can be cocked, and the elastic means can be relaxed if there is a relative rotation between the head part and the base part in the second rotational direction. The elastic means can be supported on the sliding element and on the head part or the cover part, or alternatively on the base part. The elastic means can therefore be designed as a compression spring or a tensile spring.
In the proximal position of the advancement unit, the sliding element can preferably be rotatable from a first position into a second position, wherein the sliding element can be retained by the retaining element in the first position and the sliding element can be released by the retaining element in the second position, so that the sliding element can be moved axially along the central axis (z) relative to the retaining element.
In the distal and proximal position of the advancement unit, the sliding element is preferably arranged offset from the retaining element by an angle of rotation, preferably by an angle of rotation of approximately 10°. A different angle of rotation can also be provided.
The sliding element can have a striking element for knocking the infusion set out of the retaining element, or can be constructed as a sleeve-like striking element.
The cover preferably accommodates a pushbutton. The pushbutton can be displaceable by an actuation stroke (H) along the central axis (z). In addition, the pushbutton can be designed such that when the pushbutton is pressed by the amount of the actuation stroke (H), the sliding element can be rotated about the central axis (z) relative to the retaining element by an angle of rotation into the second position.
The invention additionally relates to an insertion device for an infusion set that includes a base part comprising a mating guide element and a contact surface configured to be placed on an application point of a patient's body; a head part rotatably coupled to the base part such that the two are rotatable relative to one another about a central axis; a sliding element movable axially within an interior of the base part and the head part, the sliding element for moving the infusion set along the central axis; and an actuator for causing the sliding element to move along the central axis from a loaded position into an insertion position. Relative rotation between the head part and the base part in a first rotational direction causes a guide element associated with the sliding element to be guided with the mating guide element of the base part such that the sliding element moves along the central axis relative to the base part from an initial position into the loaded position. In the loaded position, the sliding element is rotatable about the central axis from a first position into a second position, the sliding element prevented from axial movement in the first position and movable axially relative to the retaining element in the second position. Upon actuating the actuator in the loaded position, the sliding element rotates from the first position into the second position and the sliding element is caused to move axially into the insertion position such that the infusion set is inserted at the application point.
The invention further relates to a method for inserting an infusion set by using an insertion device according to one of the preceding claims, comprising the following steps:
performing a relative rotational movement between the head part (5) and the base part (1) in a second rotational direction
inserting an infusion set into a retaining element (2)
performing a relative rotational movement between the head part (5) and the base part (1) in a first rotational direction
placing the insertion device on an application point on the body of a patient
triggering the insertion device by pressing a cover (6) or a pushbutton (7)
removing the insertion device from the application point on the patient's body.
In order to bring the insertion device back into the initial position according to
Claims
1. An insertion device for an infusion set, comprising:
- an advancement unit for moving the infusion set along a central axis from a proximal position into a distal position;
- a retaining element for retaining the infusion set, wherein the retaining element comprises a guide element;
- a base part accommodating the retaining element, wherein the base part comprises a mating guide element and a contact surface configured to be placed on an application point of a patient's body; and
- a head part rotatably coupled to the base part such that the two are rotatable relative to one another about the central axis,
- wherein relative rotation between the head part and the base part in a first rotational direction causes the guide element of the retaining element to be guided with the mating guide element of the base part such that the retaining element moves along the central axis relative to the base part from a distal position into a proximal position.
2. The device of claim 1, wherein the mating guide element is configured as a guide cam track and the guide element is configured as a guide cam.
3. The device of claim 1, wherein relative rotation between the head part and the base part in a second rotational direction causes the guide element to be guided with the mating guide such that the retaining element moves along the central axis relative to the base part from the proximal position into the distal position.
4. The device of claim 3, wherein the mating guide element is configured as a guide cam track and the guide element is configured as a guide cam.
5. The device of claim 1, wherein the advancement unit comprises an elastic means and a sliding element.
6. The device of claim 5, wherein the elastic means is caused to be cocked in response to relative rotation between the head part and the base part in the first rotational direction.
7. The device of claim 5, wherein the elastic means is supported on the sliding element and one of the head part, the cover or the base part.
8. The device of claim 5, wherein the elastic means is configured as a compression spring or as a tensile spring.
9. The device of claim 5, wherein in the proximal position of the advancement unit, the sliding element is rotatable from a first position into a second position, wherein the sliding element is configured to be retained by the retaining element in the first position and to be released by the retaining element in the second position such that the sliding element is movable axially along the central axis relative to the retaining element.
10. The device of claim 5, wherein in the distal and in the proximal positions of the advancement unit, the sliding element is arranged offset from the retaining element by an angle of rotation.
11. The device of claim 10, wherein the angle of rotation is approximately 10°.
12. The device of claim 5, wherein the sliding element comprises a striking element for knocking the infusion set out of the retaining element.
13. The device of claim 1, wherein the retaining element is rotationally fixedly connected to the head part.
14. The device of claim 1, wherein a cover is rotationally fixedly connected to the head part.
15. The device of claim 14, wherein a proximal end of the head part accommodates the cover.
16. The device of claim 14, wherein the cover accommodates a pushbutton.
17. The device of claim 16, wherein the pushbutton can be displaced by an actuating stroke along the central axis.
18. The device of claim 17, wherein the pushbutton is configured such that when displaced by the actuation stroke, the sliding element rotates about the central axis relative to the retaining element by an angle of rotation into the second position.
19. An insertion device for an infusion set, comprising:
- a base part comprising a mating guide element and a contact surface configured to be placed on an application point of a patient's body;
- a head part rotatably coupled to the base part such that the two are rotatable relative to one another about a central axis;
- a sliding element movable axially within an interior of the base part and the head part, the sliding element for moving the infusion set along the central axis; and
- an actuator for causing the sliding element to move distally along the central axis from a loaded position into an insertion position;
- wherein relative rotation between the head part and the base part in a first rotational direction causes a guide element associated with the sliding element to be guided with the mating guide element of the base part such that the sliding element moves proximally along the central axis relative to the base part from an initial position into the loaded position.
20. The insertion device of claim 19, wherein in the loaded position, the sliding element is rotatable about the central axis from a first position into a second position, the sliding element prevented from axial movement in the first position and movable axially relative to the retaining element in the second position.
21. The insertion device of claim 20, wherein upon actuating the actuator in the loaded position, the sliding element rotates from the first position into the second position and the sliding element is caused to move axially into the insertion position such that the infusion set is inserted at the application point.
22. A method for inserting an infusion set using an insertion device, comprising:
- receiving the insertion device, the insertion device comprising: an advancement unit for moving the infusion set along a central axis from a proximal position into a distal position; a retaining element for retaining the infusion set, wherein the retaining element comprises a guide element; a base part accommodating the retaining element, wherein the base part comprises a mating guide element; a head part rotatably coupled to the base part such that the two are rotatable relative to one another about the central axis; and an actuator for causing the advancement unit to move the infusion set to the distal position when actuated;
- performing a relative rotational movement between the head part and the base part in a first direction;
- inserting the infusion set into the retaining element;
- performing a relative rotational movement between the head part and the base part in a second rotational direction;
- placing the insertion device on an application point on a patient's body;
- actuating the insertion device using the actuator; and
- removing the insertion device from the application point on the patient's body.
Type: Application
Filed: Jul 28, 2015
Publication Date: Feb 4, 2016
Patent Grant number: 10335543
Inventors: Jürg Hirschel (Bern), Mario Bernhard (Burgdorf)
Application Number: 14/811,023